Massachusetts General Hospital Urine Dipstick Testing ...

1 MGH Urine Dipstick - Updated (6/30/2005 12:23 PM) Page 1 Massachusetts General Hospital Urine Dipstick Testing Using Bayer Multistix 8SG Test Strips This document outlines policies and procedures that deal with the test being described. In an effort to be concise some information may be excluded from the manufacturer s recommended procedure. It is recommended that operators familiarize themselves with the manufacturer s product information that accompanies each package. Level of Personnel: All RNs, NPs, PCAs, MAs, who have successfully completed initial training and maintained annual competency. Testing Site: All sites approved and on file with the Department of Pathology s POCT Division. Contents: Applicable Policy Statement(s) ..2 Critical Elements.

2 2 Test Kits / Supplies / Equipment ..3 Product Acquisition ..3 Specimen Collection Test Procedure ..4 - Documentation Quality Control (QC) ..5 - Quality Control Product - Critical Elements - QC Procedure - Expected Range - Range Verification - Documentation Troubleshooting and Remedial Action ..8 Operator Appendix A: Training and Assessment Record ..10 Appendix B: Answers to Quiz ..11 Appendix C: Urine Dipstick Control Validation Sheet ..12 Appendix D: Urine Dipstick Control Appendix E: Urine Dipstick Control Log Product Information / Reference Material Multistix 8 SG Reagent Strip Package Insert Kova Liqui-Trol Control Material Package Insert HMS Clinical Pathology Teaching Session Handout Reviewed and Approved by: Kent Lewandrowski, 6/1/2005 MGH Urine Dipstick - Updated (6/30/2005 12:23 PM) Page 2 Scope (Screening) Urine test strips are used for screening: Glucose, Ketone, Specific Gravity, Blood, pH, Protein, Nitrite*, and Leukocytes.

3 (*The Department of Patient Care Services does not utilize nitrite.) Urine test strips may also be used as a definitive test in managing selected drug therapies. Refer to attending physician for positive results. Additional information can be found in the manufacturer s insert provided with each container and in the reference section of this procedure. Applicable Policy Statement(s) Prior to independent patient Testing , personnel performing this test must successfully complete the certification process. Non-physician personnel must be re-certified annually. Where appropriate, each Testing area must have a documented quality control program which is developed in collaboration with or approved by the MGH Department of Pathology. Where appropriate, each Testing area must retain records that minimally identifies: (1) the patients tested, (2) their results along with the date, time performed, and the operator that performed the test, (3) products information ( , serial number, lot numbers, expiration dates, etc.)

4 And information on quality control and remedial action. All records must be maintained for no less than 2 years. Universal precautions should be instituted when handling any patient specimen. Where appropriate, a physicians order is required for performing tests. All test kits and reagents must be dated and initialed when first opened. Critical Elements 1. Test strips should be stored at room temperature. 2. The test strip container must be labeled with date when opened and initialed. 3. Opened containers must be closed immediately after removal of strip, using the original stopper, in order to avoid exposure to moisture. 4. Quality Control must be performed whenever a new container of strips is opened or whenever a container is found opened (see QC procedure).

5 5. Test pads MUST be read within specific time intervals. Leukocytes must always be read last. MGH Urine Dipstick - Updated (6/30/2005 12:23 PM) Page 3 Test Kits/Supplies/Equipment Product Vendor Manufacturer # MGH Peoplesoft # Comment Test Strips Bayer Multistix 8 SG Owens and Minor Bayer # 2164phc PS#28143 QC Product: Hycor Kova Liqua-Trol Fisher Scientific Hycor Kova Liqua-Trol 87112 Fisher Scientific #22-749755 Note: On Campus Patient Care Service sites should contact the Department of Pathology POCT Coordinator at 726-1462 for Controls. All Other Sites must purchase product from outside vendor. Request longest outdating possible. Product Acquisition Describe: _____ _____ _____ _____ Specimen Collection Collect FRESH Urine specimen in a clean, dry container.

6 Mix well before Testing . MGH Urine Dipstick - Updated (6/30/2005 12:23 PM) Page 4 Test Procedure (Manual Method) Action Consideration 1. Remove one strip from container and REPLACE CAP. 1. Replace cap immediately to avoid exposure to moisture to remaining strips. 2. QUICKLY IMMERSE reagent area of the strip COMPLETELY in fresh Urine . 2. Dip and remove immediately to avoid dissolving the reagent. 3. Remove excess Urine by drawing edge of strip along the specimen container rim then blot edge of strip on a paper towel. 3. Do not to touch pads on the paper towel. 4. Hold strip in a flat, horizontal position. 4. This avoids possible mixing of dyes and chemicals from adjacent pads. 5. Compare reagent pads to corresponding Color Chart on the bottle label.

7 Hold the strip close to the color blocks and match carefully and reading pads from bottom (glucose) to top (Leukocytes). 5. READ TIMES ARE CRITICAL. Some colors continue to intensify for a short time and then fade. ANALYTE Specific READ TIME after DIP 30 seconds 40 seconds 45 seconds 60 seconds 60 seconds 60 seconds 60 seconds - not approved for staff DO NOT READ 120 seconds COLOR CHANGES THAT OCCUR 2 MINUTES AFTER DIPPING HAVE NO DIAGNOSTIC VALUE. Documentation: Results must be recorded in one of the following manners: (1) in the patient s record, or (2) on a patient log or (3) on another approved permanent record. Note: All records must be retained and retrievable for 2 years. MGH Urine Dipstick - Updated (6/30/2005 12:23 PM) Page 5 Quality Control (QC) Quality Control Product: Hycor Liqua-Trol #87112 (Vendor: Fisher Scientific, #22-749-755) Critical Elements: 1.

8 The Hycor Liqua-Trol Human Analysis control solution should be dated and initialed when opened. 2. Liqui-Trol controls must be refrigerated when not in use. 3. The QC test results and remedial action (if any) must be documented on the QC log. 4. Label the test strip container with the date the QC was performed and your initials. (This should be the same date as when the container was initially opened.) Once the quality control has been performed and the vial remains sealed the strips may be used until the manufacture s expiration date found on the side of the vial. Procedure: Actions Consideration 1. Remove the controls from the refrigerator and allow to reach room temperature prior to Testing . 1. Controls must be returned to the refrigerator immediately after use, as they deteriorate with long exposure to light and room temperature.

9 2. Take the normal Liqua-Trol bottle and compare the lot number on the QC log with the number of the bottle; they should match. 2. A new QC log must be used when a new QC lot is used. 3. Gently swirl solution, flip open the dropper tip cap, invert and apply KOVA Liqua-Trol directly onto the reagent strips by gently squeezing the bottle. The reagent strip should be held horizontally, ensure good pad saturation and remove excess control by tilting Dipstick on its edge and blot on a paper towel. Recap control vial. 3. Test pads should not touch paper towel. Test pads should be thoroughly soaked to ensure uniformity during readings. 4. Read the Urine dipsticks pads within recommended time intervals. 4. Reading pads within specified time intervals is essential.

10 Not doing so may give erroneous results. 5. Document results on log for each pad MGH Urine Dipstick - Updated (6/30/2005 12:23 PM) Page 6 6. Compare with expected ranges 7. If outside expected ranges, reapply to pad that failed. a. If still outside of range, see troubleshooting section or contact program manager. b. If acceptable, repeat 2-7a using abnormal level 8. Recap both controls and return to refrigerator QC Reference Range: The Department of Patient Care Services (PCS) purchases a single control lot and the Department of Pathology assists the PCS Department in establishing ranges. The Department of Pathology provides QC Logs with expected ranges upon request to those Patient Care Service Units that are approved to perform UA Dipstick .